Coya completes ALSTARS enrollment with 137 patients, tops planned 120
Topline data from the Phase 2/3 trial of COYA 302 in ALS are expected in early Q2 2027, with cash now seen lasting into the second half of that year.
Coya Therapeutics said on November 10, 2026 that it had completed enrollment of 120 planned participants in the Phase 2/3 ALSTARS trial of COYA 302 for the treatment of ALS, after allowing participants in screening to enter the trial, bringing the total enrolled to 137.1
The company also said it plans to add an open-label extension to the study. In response to requests from ALSTARS investigators and study participants, Coya announced plans to initiate an open-label extension (OLE) of the ALSTARS trial, providing participants who complete the 48-week study period the opportunity to continue receiving COYA 302.1
On trial design, Coya disclosed a change to the low-dose regimen's schedule. In the low-dose regimen, subjects receive CTLA4-Ig in week 1 and low-dose IL-2 during week 3, a schedule that differs from the original design in which both agents were to be administered once per month during week 1. The revised low-dose schedule has been in place from the beginning of the trial, and the company said it preserves the mechanistic rationale of the original regimen with the same total monthly drug exposure, adding that it believes the change will have no impact on potential efficacy or safety.1
Looking ahead, Coya listed several near-term milestones. The company expects to report additional mechanistic and single-cell proteomics data from completed ALS and AD investigator-initiated trials in the fourth quarter of 2026 through the first quarter of 2027, announce biomarker data from a completed frontotemporal dementia (FTD) study in the first quarter of 2027, report topline data from the 24-week double-blind treatment phase of ALSTARS in early Q2 2027, and initiate a Phase 2 study of COYA 302 in FTD during 2027.1
On finances, Coya reported cash and cash equivalents of $35.8 million as of September 30, 2026, which it said is sufficient to fund operations, as currently planned, past the Phase 2/3 ALSTARS topline data readout and into the second half of 2027.1 Net loss for the quarter was $10.6 million, compared with a net loss of $2.1 million in the same quarter of 2025.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.